• ICH Q9: Pharmaceutical Quality Risk Management (QRM) Benefits and Challenges
• Process Analytical Technology (PAT) and Control Strategy Development
• Pharmaceutical Manufacturing and QbD: Design Space
• Applying Risk Management for Approved Products
• Identifying Critical Process Parameters in Drug Substance Manufacture
• API Process Simplification and Scale-Up Leading to QBD
• Raw Material Identification by Near Infrared Spectroscopy (NIR)
• Particle Size Analysis with Focused Beam Reflectance Measurement (FBRM)
• QbD Implementation for Regulatory Products
• Examining the Novartis/FDA CRADA QbD project
• Design of Experiments (DoE) Techniques
• Multivariate Data Analysis (MVDA) and Defining DesignSpace
• How to Implement QbD Concepts into a Pharmaceutical Development Organization
• How to Use Risk Management Methods and Tools

This two day conference is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical and allied industries with responsibilities in the follow areas:

• Risk Management and Risk Assessment
• Quality Assurance
• Quality Control
• Process Management
• Analytical Development
• R&D
• Design and Formulation
• Manufacturing
• Formulation
• Validation
• Engineering
• Statistics
• Regulatory Affairs
• Technical Services
• Project Management
• Operations
• Production